06/05/2026 InflaRx announced advancement of Izicopan in AAV and select renal diseases SynAct Pharma completed dosing for the last patient in Phase 2b study for RA InflaRx announced advancement of Izicopan in AAV and select renal diseases (Ref) InflaRx announced that it intended to develop izicopan (an oral C5a receptor inhibitor) in ANCA-Associated Vasculitis (AAV). InflaRx was conducting Phase 2 planning for izicopan in AAV and was evaluating the feasibility of multiple deve

05/05/2026 J&J announced Phase 2b data from two studies in IBD J&J announced Phase 3 results for guselkumab in CD Avalo Therapeutics announced positive Phase 2 results for abdakibart in HS J&J announced Phase 2b data from two studies in IBD (Ref) Johnson & Johnson announced data from two Phase 2b studies, DUET-UC/ NCT05242484 and DUET-CD/ NCT05242471, which evaluated JNJ-4804 (IL-23 and TNF-α) in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s

04/05/2026 Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC (Ref) Mirum Pharmaceuticals announced that the primary endpoint was met in the Phase 2b, VISTAS study, which evaluated volixibat (an IBAT inhibitor) in patients with primary sclerosong cholangitis (PSC). Volixibat demonstrated a statistically significant and clinically m

03/05/2026 UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers (Ref) UCB announced that it had signed a definitive agreement to acquire Candid Therapeutics, a privately held clinical-stage biotechnology company developing novel T-cell engagers for the treatment of autoimm

30/04/2026 Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations (Ref) Merck announced that the first patient had been dosed in the Phase 3 program, ELOWEN-1/ NCT07332481and ELOWEN-2/ NCT07355218, evaluating enpatoran (TLR 7/8 inhibitor) in people living with lupus who experience active skin man

29/04/2026 Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA (Ref) Hutchmed announced that the New Drug Application (NDA) for sovleplenib (a spleen tyrosine kinase) for the treatment of adult patients with warm antibody autoimmune hemolytic ane

28/04/2026 AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA InnuCare announced that the first patient had been dosed in a Phase 3 trial of orelabrutinib for SLE AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA (Ref) AbbVie announced that it had submitted an application to the US FDA for RINVOQ® (upadacitinib; JAK inhibitor) for the treatment of adult and adolescent patien

27/04/2026 AbbiVe submitted a regulatory application to the FDA for risankizumab for adults with moderately to severely active CD Saphnelo was approved in the US for subcutaneous self-administration for the treatment of SLE Novartis announced that remibrutinib had received EU approval for the treatment of chronic spontaneous urticaria The FDA granted Priority Review for nipocalimab for the treatment of wAIHA AbbiVe submitted a regulatory application to the FDA for risankizuma

24/04/2026 Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses (Ref) Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib; BTK inhibitor) in the EU for the

22/04/2026 Roche announced Phase 3 data for fenebrutinib in RMS Johnson & Johnson announced Phase 3 data for nipocalimab in gMG Sanofi's Tzield approved in the US to delay the onset of stage 3 T1D in young children Roche announced Phase 3 data for fenebrutinib in RMS (Ref) Roche announced new positive data from the Phase 3 FENhance 1 and 2 studies, Which investigated fenebrutinib (BTK inhibitor) for the treatment of patients with Relapsing Multiple Sclerosis (RMS). FENhance 1

21/04/2026 FDA accepted application for Roche’s Gazyva for the treatment of SLE Cristcot announced FDA acceptance of NDA for ngHCA for treatment of UC of the Rectum AstraZeneca announced Phase 3 results for ravulizumab for IgA Nephropathy FDA accepted application for Roche’s Gazyva for the treatment of SLE ( Ref ) Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment o

20/04/2026 Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA Biogen entered into agreement with TJ Biopharma for felzartamab in the Greater China Region Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA ( Ref ) Nektar Therapeutics announced topline results from its Phase 2b REZOLVE-AA/ NCT06340360 study, which evaluated rezpegaldesleukin (IL-2 pathway agonist) f

15/04/2026 Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP ( Ref ) Savara announced that the FDA had extended the review period for the malgramostim ( Molgramostim Inhalation Solution ) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months The Agency was reviewing the molgramostim BLA under Pr

07/04/2026 Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN ( Ref ) Climb Bio announced that the US FDA had granted Fast Track Designation to budoprutug (anti-CD19 mAb) for the treatment of primary membranous nephropathy (pMN) Brudoprutug was being studied in Phase 2 patinets with pMN The company anticipated initial data from Phase 2 study in H2 2026

06/04/2026 Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 Amgen announced topline results from Phase 3 teprotumumab in active TED Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 ( Ref ) Tenvie Therapeutics announced the first subject dosed in a Phase 1 clinical study evaluating TNV262 (a fully CNS-penetrant small molecule inhibitor targeting NLRP3) for the treatment of cardiometabolic diseases, including obesi

02/04/2026 Immunovant announced Phase 3 results for batoclimab in thyroid eye disease Immunovant announced Phase 3 results for batoclimab in thyroid eye disease ( Ref ) Immunovant announced topline results from its two Phase 3 (GO) studies that evaluated batoclimab (an FcRn antagonist) for the treatment of adult patients with active, moderate-to-severe thyroid eye disease (TED) The studies failed to meet their primary endpoint of achieving ≥2mm proptosis responder rate at We

01/04/2026 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 ( Ref ) Alkermes announced the initiation of the Phase 3 Brilliance studies program, which evaluated the safety and efficacy of alixorexton (ALKS 2680; selective OX2R agonist) for the treatment of adult patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) T

30/03/2026 Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences Savara announced EMA validation of MAA for MOLBREEVI in autoimmune PAP Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences ( Ref ) Aurinia Pharmaceuticals entered into a definitive merger agreement to acquire Kezar life sciences for $6.955 per share in cash, plus one non-transferable Contingent Value Right (CVR), which represents the right to receive: Potential payments from the

28/03/2026 Biogen announced Phase 2 results for litifilimab for CLE Results from Sanofi’s Phase 3 studies in AD were presented AAD Alumis announced Phase 3 data for envudeucitinib for plaque psoriasis Incyte announced Phase 3 data for povorcitinib for HS Biogen announced Phase 2 results for litifilimab for CLE ( Ref ) Biogen announced positive results from part A of its Phase2/3 AMETHYST/ NCT05531565 study, which evaluated litifilimab (BDCA2) for the treatment of patients w

26/03/2026 UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG ( Ref ) UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add